More than 20,000 people have claimed that the anticoagulant Xarelto caused them injuries, especially in the form of uncontrolled bleeding. They also claim that manufacturers have not warned sufficiently about the possible fatal side effects of the drug.
While there is always a risk of side effects with all medications, whether mild or severe, manufacturers, prescribers and sellers also need to ensure that potential side effects are clearly available to the public to understand.
Legal action against developers Bayer Pharmaceuticals and the company that markets Johnson & Johnson's Xarelto, Janssen Pharmaceuticals has resulted in an agreement of $ 775 million in 2019. This resolves approximately 25,000 legal disputes related to internal bleeding risks and a lack of warning. If a patient or family believes that a drug has harmed them due to illness, injury, or even death, they can file a lawsuit for damages that may cover expenses such as medical bills, funeral expenses, or loss of income. amongst other things.
What is Xarelto?
Xarelto is a prescription anticoagulant (or blood thinner) used to prevent blood clots. It is prescribed to people with atrial fibrillation, heart disease that causes an irregular or abnormally fast heartbeat, and people who are prone to deep vein thrombosis (DVT) or pulmonary embolism. It can also be prescribed to people after hip or knee surgery to prevent blood clots. It is an oral medication that can be found under the generic name of rivaroxaban. How often it is taken depends on the condition being treated. It is usually taken once a day, sometimes with a meal, and may be used more often to treat blood clots.
As with most medications, side effects can occur when taking Xarelto. Some of them may have mild bruising or bleeding. However, it can also cause severe bleeding in some people, which can lead to hospitalization or the need for a blood transfusion, and can even result in death. Many drugs have side effects and are prescribed by medical professionals on the basis that the benefits of the drugs outweigh the associated risks. Xarelto not only claimed that the manufacturer had not properly warned about the risks of taking the drug, but research has also shown that the potentially fatal side effects are not offset by the benefits.
Xarelto is the best-selling drug from Bayer. Sales of the drug brought the German pharmaceutical company 2018 3.6 billion euros. Janssen Pharmaceuticals from Johnson & Johnson sells the drug in the United States under a license agreement. It has been approved by the United States Food and Drug Administration since 2011. The two companies that developed the drug believe that the warning label contains accurate and complete information about its benefits and risks.
Xarelto Benefits vs Risks Research
In 2017, Bayer and Johnson & Johnson conducted a study on the benefits of Xarelto that was weighed against the serious side effects. However, the study was suspended after an external research group published results showing that Xarelto was no more effective than secondary treatment standards involving aspirin and other over-the-counter medications for secondary stroke prevention. While research showed that the use of Xarelto is of no greater benefit, there are some significant risks with the possible side effects. Internal bleeding is one of them and a side effect that Johnson & Johnson has not warned of.
Injuries caused by Xarelto
The FDA says blood-thinning medications have been linked to more than 370 internal bleeding-related deaths. Two common injuries associated with the use of Xarelto in court cases are bleeding events that required blood transfusions and bleeding events that required hospitalization, serious injury, and even death.
Xarelto is often prescribed for use after hip or knee surgery. Higher rates of wound infections and complications have been associated with the use of Xarelto after these operations. In addition, people who take Xarelto may be at greater risk of returning to surgery within 30 days than people who do not take Xarelto. Some surgeons choose to use other anticoagulants that are not at risk of such serious complications.
Xarelto can cause heavy bleeding if it affects the blood clotting proteins too much. Anyone taking it should watch for signs of serious build-up, such as pain, swelling and discomfort, unusual bruising, persistent bleeding, persistent nosebleeds, coughing up blood and severe headaches.
Side effects of the drug can include:
- Uncontrollable internal bleeding
- Cerebral hemorrhage
- Bleeding from the bowels or abdomen
- Prolonged bleeding from cuts or gums
- Loss of ability to control movement
- Numb or tingly muscles
- Abnormal liver function
- Reduced platelet levels
- Dizziness and fainting
- Bladder and bowel disorders
Other things that people should consider before taking the drug are their medical history, especially if they have had bleeding disorders, kidney disease, liver disease, and various other health conditions in the past. Anyone taking Xarelto or Rivaroxaban should tell their doctor or dentist about this before surgery or dental surgery.
Current Xarelto lawsuits
With more than 20,000 people claiming that Xarelto caused uncontrollable bleeding and the manufacturer had not given an adequate warning, there was no shortage of lawsuits against Bayer Pharmaceuticals and Janssen Pharmaceuticals. Many of the lawsuits have been consolidated into litigation in multiple districts in Louisiana.
In addition to the allegations of the side effects of the drug and the alleged lack of adequate warning, criticism was also raised regarding both the narrow therapeutic index and the lack of antidotes. A narrow therapeutic index means that there is a narrow window between a safe and a dangerous dose. Until 2018, there was no antidote to uncontrolled bleeding caused by drugs like Xarelto. Although it is now available, the Andexxa drug is expensive and not widely available.
There have also been similar lawsuits against Boehringer Ingelheim that make a blood thinner called Pradaxa. This lawsuit resulted in a $ 650 million settlement in 2014, which was paid to individuals who have served as compensation for injuries related to the use of Pradaxa in more than 4,000 cases. Another oral blood thinner, Pfizer's Eliquis, has also been the subject of lawsuits, but most of them have been dismissed by US judges.
The lawsuits related to Xarelto were collected in 2014 and consolidated in a federal court in New Orleans. In more than four years and in six court cases, many people were represented by lawyers who discussed their case both in court and out of court.
Three cases were selected to determine the range of compensation and settlement options. These three cases were won by Bayer and Janssen Pharmaceuticals in 2017, followed by three other cases where they were released from liability in 2018.
In March 2019, Bayer and Janssen Pharmaceuticals reached an agreement of $ 775 million to resolve around 25,000 cases of people. This means that of those who claimed that Xarelto had caused internal bleeding risks and had not been warned by the manufacturer, the average billing amount per person was $ 31,000, although there was no official estimate of how many people would receive. The agreement also applied to new applicants who were not part of the multidistrict litigation, but who had retained a lawyer before March 11, registered their application by March 28, and filed an action by April 4, 2019.
Those who filed suit on or after December 1, 2015 indicated that payments received would be reduced compared to those who previously filed suit. Those who suffered an injury on or after March 1, 2016 would also receive reduced payments.
Of the cases brought before the court, Bayer and Janssen Pharmaceuticals won six cases. However, they said the deal would allow them to "avoid the distraction and significant costs" that would result from continuing litigation related to the use of Xarelto. Janssen Pharmaceuticals stated that the settlement was not a disclaimer and that the claims made were against scientific data and the confirmation from the USFDA that Xarelto was and was safe to use.
An agreement in a Xarelto process was revoked in 2018. A state jury in Philadelphia originally ordered the payment of $ 27.8 million to an Indiana woman, Lynn Hartman, who was hospitalized for gastrointestinal bleeding after using Xarelto for a year. However, the trial judge overturned the verdict, which Hartman's lawyer said was due to a close problem with Hartman's doctor.
The large settlement on Xarelto lawsuits has resulted in many people receiving compensation for injuries allegedly caused by Xarelto. It shows the power of litigation with multiple counties and class action lawsuits. However, this has also meant that future lawsuits against Xarelto may not be wise.